Methods and compositions of stable phenylephrine formulations
OwnerPatrick H. Witham, Sailaja Machiraju +1inventors
InventorsPatrick H. Witham, Sailaja Machiraju, Lauren Mackensie-Clark Bluett
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Abstract
The invention is directed to methods and compositions of stabilizing phenylephrine formations. The composition has good time-dependent stability at low temperature and has no change in its outward appearance even after having been stored at least 6 months.
Claims18
A method of dilating a pupil of a subject in need thereof, the method comprising storing a comprising R-phenylephrine hydrochloride and an aqueous buffer at a temperature between −10 to 10 degree Celsius prior to use and subsequently administering the composition to an eye of the subject, wherein the composition has a pH of fromabout 6.0 to about 6.7 when stored prior to administration, and wherein the composition comprises R-phenylephrine hydrochloride having an initial chiral purity of at least 95% enantiomeric excess (ee) as determined by chiral column chromatography at a time prior to storage and a chiral purity of at least 95% (ee) as determined by chiral chromatography at the time of use after storage when administered to the pupil of the subject, and wherein storing the composition at a temperature between −10 to 10 degrees Celsium maintains the chiral purity of at least 95% (ee) as determined by chiral column chromatography for a period of at least 6 months storage.
Dependencies are inferred from the claim text.